BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    WALLAC NEONATAL LEUCINE TEST KIT MODEL NL-1000

    K Number: K982307 · Decision Feb 2, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    14
    Applicant Total
    2
    Review Days
    216

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    Basic Information

    Device Name
    WALLAC NEONATAL LEUCINE TEST KIT MODEL NL-1000
    K Number
    K982307
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1555
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Wallac, Inc.
    Date Received
    July 1, 1998
    Decision Date
    February 2, 1999
    Product Code
    JNB
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JNB Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine

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    Other Clearances by Wallac, Inc.

    K Number Device Name
    DEN990008 WALLAC NEONATAL BIOTINIDASE TEST KIT, MODELS NB-1000; NB-4000